Back to resultsA Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
Primary Purpose
Advanced Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis (clinical stage: cT2-4 and N+)
- At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0)
- age between 18 and 75 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- no prior chemotherapy or radiotherapy
- adequate bone marrow, hepatic and renal function (absolute neutrophil count [ANC] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal [ULN], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).
Exclusion Criteria:
- clinical stage T1 tumors
- clinical or radiologic evidence of distant metastasis
- intestinal obstruction or impending obstruction
- active tumor bleeding
- interstitial pneumonitis or symptomatic pulmonary fibrosis
- peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade ≥1
- pregnant or breastfeeding patients
- other serious diseases
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mFOLFOX6
Arm Description
Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
Outcomes
Primary Outcome Measures
clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy
Secondary Outcome Measures
Time to progression
overall survival
Full Information
NCT ID
NCT01851941
First Posted
May 6, 2013
Last Updated
May 8, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01851941
Brief Title
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC) with regional lymph node metastasis is still in the area of controversy. The aim of this study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with regional lymph node (LN) metastasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mFOLFOX6
Arm Type
Experimental
Arm Description
Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )
Intervention Description
Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
Primary Outcome Measure Information:
Title
clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy
Time Frame
4 cycles of chemotherapy (expected average of 8 weeks)
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
From date of study enrollment until the date of first documented progression, assessed up to 60 months
Title
overall survival
Time Frame
From date of study enrollment until the date of first documented progression, assessed up to 60 months
Other Pre-specified Outcome Measures:
Title
gene expression profile
Time Frame
after 4 cycles of chemotherapy (expected average of 8 weeks)
Title
early metabolic response by PET-CT
Time Frame
2 cycles of chemotherapy (expected average of 4 weeks)
Title
Pharmacologic Genetic Marker
Time Frame
4 cycles of chemotherapy (expected average of 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis (clinical stage: cT2-4 and N+)
At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0)
age between 18 and 75 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
no prior chemotherapy or radiotherapy
adequate bone marrow, hepatic and renal function (absolute neutrophil count [ANC] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal [ULN], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).
Exclusion Criteria:
clinical stage T1 tumors
clinical or radiologic evidence of distant metastasis
intestinal obstruction or impending obstruction
active tumor bleeding
interstitial pneumonitis or symptomatic pulmonary fibrosis
peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade ≥1
pregnant or breastfeeding patients
other serious diseases
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
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